Frontier Registry II Bifurcation Stent System Registry

The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II

To assess the procedural success, performance, 30-day and 6 month clinical outcome of bifurcation stenting, and the six month incidence of clinically indicated target lesion revascularization with the use of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System in patients with de novo or restenotic bifurcation lesions.

The purpose of this study is to assess the performance of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System (CBSS) with one and six months clinical outcomes, when used for bifurcation de novo or restenotic lesion treatment. The device allows for a stent to be implanted in the main branch and simultaneous preservation and access of the side branch for balloon dilatation or stenting when indicated.

Inclusion Criteria:

• Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure.
• Native parent vessel suitable to receive at least a 2.5mm x 18mm FRONTIER stent (>2.5mm and <4.0mm diameter with a side branch of >2.0mm) with a lesion length <15mm determined by visual assessment .
• Target main branch vessel must be a major epicardial native vessel.
• Appropriate lesion morphology.
• Target lesion is restenosis following original treatment by PTCA only (no in-stent restenosis).

Exclusion Criteria:

• Estimated artery reference diameter <2.5mm
• Patients with diffuse disease defined as long segments of abnormal vessel without interposed areas of normal vessel
• Target lesion contains thrombus.
• Target lesion is aorto-ostial or left main stem location.
• Untreated lesion >50% diameter stenosis proximal or distal to target lesion after the planned target lesion intervention.
• Patients with a contraindication for anti-platelet / anti-coagulation therapy.
• Target lesion distal to previously placed stents.
• Fibrotic or calcified lesions that cannot be pre-dilated.